Civica Rx (Civica, Inc.) and Exela Pharma Sciences, LLC (“Exela”), today announce a long-term agreement to manufacture and supply Civica's growing membership of U.S. health systems with sodium bicarbonate injection, which has been in critically short supply in U.S. hospitals.
Exela, founded in 2005, recently received approval from the U.S. Food and Drug Administration (FDA) to manufacture sodium bicarbonate, which is used for emergency care in hospitals to treat metabolic acidosis which may be due to severe kidney disease, cardiac arrest, uncontrolled diabetes and circulatory insufficiency due to shock or severe dehydration. Civica member hospitals have prioritized sodium bicarbonate as an urgent medical need because they’ve had to ration use of the medication due to ongoing shortages.
Under the agreement, Exela will produce sodium bicarbonate for Civica, using Exela’s Abbreviated New Drug Application (ANDA) and Civica's labeling and National Drug Code (NDC). First deliveries to hospitals are expected this year.
“Exela continues to demonstrate its commitment to addressing shortages of this vital medication and we thank them for their partnership,” said Martin VanTrieste, President and CEO of Civica Rx. “Sodium bicarbonate is a medicine that is a staple on hospital crash carts and often used for emergency resuscitations. No hospital or patient should ever have to go without it.”
Civica, founded last year by leading U.S. health systems and philanthropists, acts in the best interest of patients to eliminate uncertainty in the generic drug supply chain through long-term contracts with health system members as well as its manufacturing partners. To date, 39 health systems are Civica members, representing more than 1000 U.S. hospitals.
“We are pleased to be able to step in at this critical time and welcome the opportunity to work with Civica to ensure their member hospitals have sufficient supply of sodium bicarbonate,” said Phanesh Koneru, President and CEO of Exela Pharma Sciences. “Collaborating to alleviate drug shortages is an important way to achieve our mission of providing access to affordable medicines.”
About Civica Rx
Civica Rx was established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (the Laura and John Arnold Foundation, the Gary and Mary West Foundation and the Peterson Center on Healthcare) to reduce chronic generic drug shortages in the United States. It exists in the public interest as a non-profit, non-stock corporation committed to stabilizing the supply of essential generic medications in a hospital setting.
Civica is committed to transparency and will offer fair and sustainable prices to its member hospitals. It will also ensure it has dedicated manufacturing capacity for the medications that are most desperately needed in hospitals across the country through redundant manufacturing and strategic stockpiling of medications to prevent drug shortages in the future.
Civica aims to stabilize the supply of antibiotics, anesthetics, cardiac medications, pain management medications, and other essential sterile injectable medicines used in hospitals daily. It is actively pursuing a three-pronged product supply strategy:
- Working with multiple generic drug manufacturers that have the US FDA approved manufacturing facilities and capacity to produce Civica labeled generic drugs, allowing manufacturers to re-enter the market or increase existing capacity. Civica recently announced partnerships with Hikma Pharmaceuticals to provide 14 medicines are used daily by hospitals in emergency care, surgery, pain management and in treating hypertension, and Xellia Pharmaceuticals to provide two critical antibiotics, Vancomycin and Daptomycin.
- Developing and acquiring Abbreviated New Drug Applications (ANDAs) for generic drugs and working with contract manufacturing organizations to produce Civica medications.
- Acquiring and building Civica manufacturing facilities using Civica's ANDAs.
Find more information about Civica at www.civicarx.org.
About Exela Pharma Sciences
Exela Pharma Sciences, a fast-growing specialty pharmaceutical company, focuses on developing, manufacturing and marketing proprietary and generic injectable products with the healthcare provider and patient in mind. Our goal is to deliver high quality, affordable products that make a difference in people’s lives and add value to the healthcare providers that treat them. Built from a strong Research and Development, Regulatory and Quality foundation, Exela is focused on delivering excellence in Quality, Reliability and Affordability. Established in 2005 by a former Pharmacist, Exela is headquartered in Lenoir, N.C. Please visit www.exelapharma.com to learn more.
Civica Rx, Debbi Ford, +1 970 227 3991, Debbi.firstname.lastname@example.org
Exela Pharma Sciences, Mark Hartman, +1 704 999 1916, email@example.com